Vaccine Therapy in Treating Patients With Metastatic Melanoma

Melanoma (Skin) Clinical Trial

Official title:

Mature Dendritic Cell Immunotherapy Of Metastatic Melanoma- A Phase I Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00017355
• Other study ID #: CDR0000068680
• Secondary ID: BAYUMC-000048NCI
• Status: Active, not recruiting
• Phase: Phase 1
• First received: June 6, 2001
• Last updated: September 16, 2013
• Start date: April 2001

Study information

• Verified date: March 2003
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Vaccines made from a patient's white blood cells mixed with tumor antigens may make the body build an immune response to kill tumor cells.

PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who have metastatic melanoma.

Description:

OBJECTIVES:

• Determine the safety and tolerability of antigen-pulsed dendritic cell vaccine in patients with metastatic melanoma.

• Determine the longevity of melanoma-specific immunity in patients treated with this regimen.

• Perform serial analysis of T-cell and B-cell function in patients treated with this regimen.

OUTLINE: Patients receive filgrastim (G-CSF) subcutaneously (SC) once daily on days 1-6 or 1-7. Patients undergo apheresis on days 6 and 7 or 6-8 to obtain peripheral blood mononuclear cells (PBMC). PBMC are processed for CD34+ cell isolation. These autologous CD34+ hematopoietic progenitor cells are cultured to generate dendritic cells (DC). DC are then pulsed with endotoxin-free keyhole limpet hemocyanin and HLA-A2-01 restricted flu-matrix peptides derived from melanoma-associated tumor antigens (MART-1:27-35, gp100:209-217, and MAGE-3). Antigen-pulsed DC are incubated with interferon alfa to induce DC maturation.

Patients receive priming injections of antigen-pulsed DC vaccine SC once every 2 weeks for 8 weeks. Treatment repeats at 2, 3, 4, and 5 months after the last priming injection in the absence of unacceptable toxicity or disease progression.

Patients are followed at 2 and 4 weeks and then every 3 months for 1.5 years.

PROJECTED ACCRUAL: A total of 18 patients will be accrued for this study.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Histologically confirmed metastatic melanoma

• HLA-A2-01 phenotype

• Measurable disease

• No active CNS or hepatic metastases

PATIENT CHARACTERISTICS:

Age:

• 21 and over

Performance status:

• Karnofsky 80-100%

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• See Disease Characteristics

• No viral hepatitis

Renal:

• Not specified

Cardiovascular:

• No prior venous thrombosis, angina pectoris, or congestive heart failure

• Lactate dehydrogenase less than 2 times normal

Pulmonary:

• No prior asthma

Immunologic:

• Intradermal skin test positivity to mumps, Candida, or streptokinase antigen

• No known sensitivity to E. coli drug preparations

• No prior allergy to influenza vaccine

• No active infection

• No prior autoimmune disease (e.g., lupus erythematosus, rheumatoid arthritis, or thyroiditis)

Other:

• HIV negative

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• At least 8 weeks since prior interleukin-2

• At least 4 weeks since prior interferon alfa

Chemotherapy:

• At least 8 weeks since prior chemotherapy

Endocrine therapy:

• At least 2 weeks since prior corticosteroids

• No concurrent corticosteroids

Radiotherapy:

• Not specified

Surgery:

• Not specified

Other:

• No concurrent immunosuppressive agents

• At least 2 weeks since prior immunosuppressive agents

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Melanoma
• Melanoma (Skin)

Intervention

Biological:
• filgrastim

• therapeutic autologous dendritic cells

Locations

Country	Name	City	State
United States	Baylor University Medical Center	Dallas	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Baylor Health Care System	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,